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U.S. Department of Health and Human Services

Class 2 Device Recall HardyCHROM MRSA

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 Class 2 Device Recall HardyCHROM MRSAsee related information
Date Initiated by FirmJuly 09, 2015
Date PostedAugust 26, 2015
Recall Status1 Terminated 3 on November 10, 2015
Recall NumberZ-2463-2015
Recall Event ID 71804
510(K)NumberK102922 
Product Classification Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
ProductHardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
Code Information Cat no. G307 Lot no. H15155
Recalling Firm/
Manufacturer
Hardy Diagnostics
1430 W Mccoy Ln
Santa Maria CA 93455-1005
For Additional Information ContactTechnical Services Department
800-266-2222 Ext. 2
Manufacturer Reason
for Recall
Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.
FDA Determined
Cause 2
Unknown/Undetermined by firm
ActionThe firm initially notified customers via phone to inform them of a recall. The phone scripts asks customers if they have had any issued with the QC testing. The firm states that our of a precaution they are asking customers to discard the remaining plates of the identified lot, and that credit or replacement plates will be offered for any remaining. The firm followed-up phone calls with a written notification letter. The letter states to complete, sign, and fax or email back the enclosed form stating compliance with the above action. The letters states that is the customer could not be reached via phone and would like replacements or credit to contact the Customer Service Department at 800-266-2222, option 1. Any questions call the Technical Services Department at 800-266-2222, option 2 or email at techservice@hardy diagnostics.com.
Quantity in Commerce2,820 (282 pk/10)
DistributionDistributed in the states of VA, PA, NY, NJ, IL, OH, and MD.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JSO
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